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Combination therapy with mek inhibitor, pd-1 axis inhibitor, and taxane

A PD-1, PD-L1 technology, applied in drug combinations, chemical instruments and methods, antibody medical components, etc., can solve problems such as resistance occurrence and non-persistent response

Inactive Publication Date: 2019-06-07
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although mTNBC responses to chemotherapy are common, responses are not durable and resistance is likely to develop

Method used

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  • Combination therapy with mek inhibitor, pd-1 axis inhibitor, and taxane
  • Combination therapy with mek inhibitor, pd-1 axis inhibitor, and taxane
  • Combination therapy with mek inhibitor, pd-1 axis inhibitor, and taxane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0280] Example 1 Involving a Cohort I Dose Expansion Study of Patients Treated on a 21 / 7 Schedule, the Primary Objective was to Evaluate the Maximum Tolerability of the Combination of Cobimetinib and Paclitaxel Relative to the Combination of Placebo and Paclitaxel dose (MTD) and clinical benefit, as measured by investigator-assessed PFS.

[0281] Cohort I further includes the following targets:

[0282] The ORR, ORR_uc and DOR of (i) cobitinib and paclitaxel and (ii) placebo and paclitaxel were evaluated.

[0283] To assess the OS benefit of cobitinib plus paclitaxel versus placebo plus paclitaxel.

[0284] To evaluate the safety and tolerability of cobimetinib administered in combination with paclitaxel. Criteria include measuring the nature, frequency, and severity of adverse effects graded using NCICTCAE v4.0. Measured effects included changes in vital signs and clinical laboratory results during and after administration of cobimetinib and paclitaxel.

[0285] To assess...

Embodiment 2

[0292] Example 2 concerns a cohort II study of the triple combination of cobimetinib, atezolizumab and paclitaxel in mTNBC patients.

[0293] Cohort II includes the following targets:

[0294] The clinical benefit of cobimetinib, atezolizumab, and paclitaxel, as measured by ORR, was assessed.

[0295] Determine the ORR_uc and DOR of cobitinib, atezolizumab and paclitaxel, and evaluate the OS and PFS of cobitinib, atezolizumab and paclitaxel.

[0296] To evaluate the safety and tolerability of cobimetinib, atezolizumab and paclitaxel. The nature, frequency, and severity of adverse events will be graded using NCI CTCAEv4.0. Changes in vital signs and clinical laboratory results during and after administration of cobimetinib, atezolizumab, and paclitaxel will be measured.

[0297] To evaluate the pharmacokinetics of cobimetinib, atezolizumab, and paclitaxel when administered together (safety insert). The pharmacokinetic assessment in the safety insert phase will examine the p...

Embodiment 3

[0309] Example 3 concerns a cohort III study of the triple combination of cobimetinib, atezolizumab and nab-paclitaxel in mTNBC patients.

[0310] Cohort III includes the following goals:

[0311] The clinical benefit of cobimetinib plus atezolizumab plus nab-paclitaxel, as measured by ORR, was assessed.

[0312] To determine the ORR_uc and DOR of cobitinib, atezolizumab and nab-paclitaxel, and to evaluate the OS and PFS of cobitinib, atezolizumab and nab-paclitaxel.

[0313] To evaluate the safety and tolerability of cobimetinib, atezolizumab and nab-paclitaxel. The nature, frequency, and severity of adverse events will be graded using NCI CTCAEv4.0. Changes in vital signs and clinical laboratory results during and after administration of cobimetinib, atezolizumab, and nab-paclitaxel will be measured.

[0314] Assess the PK of cobimetinib, atezolizumab, and nab-paclitaxel when administered together (safety insert). The PK assessment in the safety insert phase will examine...

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Abstract

A combination therapy comprising a MEK inhibitor, a PD-1 or PD-L1 inhibitor, and a taxane is provided for the treatment of cancer, such as triple negative breast cancer.

Description

[0001] Cross references to related applications [0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 401638, filed September 29, 2016, which is incorporated herein in its entirety. field of invention [0003] The field of the present disclosure generally relates to combination cancer therapies of MEK inhibitors, PD-1 axis inhibitors, and taxanes. Background of the invention [0004] Globally, breast cancer is the most common invasive malignancy and the most common cause of cancer-related death in women (Siegel R, DeSantis C, Virgo K et al., Cancer treatment and survival statistics, 2012. CA Cancer J Clin 2012;62: 220-41), the 5-year survival rate after metastatic diagnosis is approximately 15%. About 180,000 women are diagnosed with breast cancer in the United States each year, 40,000 of whom will die from the disease (Jema et al. 2008), and the lifetime probability of developing invasive breast cancer in the United States and Europe is on...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K31/337A61K31/4523A61P35/00C07K16/28
CPCA61K39/3955A61K31/337A61K31/4523C07K16/2827A61K2039/505C07K2317/24C07K2317/76A61K45/06A61P35/00A61K2300/00A61K39/39558A61K2039/545A61K2039/54A61K47/643A61K47/6921A61K39/39566C07K2317/56
Inventor N·钟V·麦克纳利
Owner GENENTECH INC